Product Classification

Infusion safety management software is a prescription device intended for use with infusion pumps and may include one or more of the following capabilities: prepopulation of infusion programming parameters, data retrieval and analysis for tracking and trending, drug infusion error reduction algorithms, and alarm transmission.

Physical State

The device is a software application(s), which may be implemented as part of an infusion pump and may also be implemented onto a hospital information system for use with an infusion pump system.

Technical Method

Infusion safety management software may include one or more software applications that enforce safety control mechanisms through wireless or wired communication between the hospital information system, the infusion pump, and the healthcare provider.

Target Area

Target area is according to the approved drug or biologic product labeling.